Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?
|ClinicalTrials.gov Identifier: NCT01730846|
Recruitment Status : Completed
First Posted : November 21, 2012
Results First Posted : December 20, 2017
Last Update Posted : February 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Smoking||Drug: Doxazosin 4mg/day Drug: Placebo Drug: Doxazosin 8mg/day||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Does Doxazosin Attenuate Stress-induced Smoking and Improve Clinical Outcomes?|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
Experimental: Doxazosin 4mg/day
Drug: Doxazosin 4mg/day
4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
Other Name: Cardura
Placebo Comparator: Placebo
Experimental: Doxazosin 8mg/day
Drug: Doxazosin 8mg/day
8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
Other Name: Cardura
- Latency (Min) to Initiate Ad-lib Smoking Session [ Time Frame: 0 up to 50 minutes (Delay Period) ]Latency to start smoking in the stress and neutral ad-lib smoking lab sessions. Subjects had the opportunity to delay smoking for 50 minutes (delay period). Once the subject decides to smoke, the 1 hour ad-lib smoking session begins. They can chose to smoke as little or as much as they wish.
- Number of Cigarettes Smoked During Ad-lib Session [ Time Frame: 60 minutes (ad-lib smoking period) ]
Number of cigarettes smoked during the stress and neutral ad-lib smoking period.
Once the subject decides to smoke (delay period), the 1 hour ad-lib smoking period begins. They can chose to smoke as little or as much as they wish.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730846
|United States, Connecticut|
|Yale Center for Clinical Investigations, Yale University|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Sherry A McKee, PhD||Yale University|